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ENGLISH
ZENITH ALPHA™ ABDOMINAL ENDOVASCULAR GRAFT
Read all instructions carefully . Failure to properly follow the instructions,
warnings and precautions may lead to serious surgical consequences or
injury to the patient .
CAUTION: Federal (U .S .A .) law restricts this device to sale by or on the
order of a physician .
CAUTION: All contents of the outer pouch (including the introduction
system and endovascular grafts) are supplied sterile, for single use
only .
For the Zenith product line, there are several applicable Suggested
Instructions for Use (IFU) . This IFU describes the Suggested Instructions for
Use for the Zenith Alpha Abdominal Endovascular Graft and Zenith Alpha
Spiral-Z Endovascular Leg (main body, iliac legs, main body extension and
converter) . For information on other Zenith components, please refer to the
following Suggested Instructions for Use:
• Zenith® Low Profile Endovascular Graft;
• Zenith® Branch Endovascular Graft-Iliac Bifurcation;
• Zenith® Renu™ AAA Ancillary Graft;
• Zenith Alpha™ Spiral-Z® Endovascular Leg;
• Zenith® Spiral-Z AAA Iliac Leg with the Z-Trak™ Introduction System;
• Zenith® AAA Ancillary Components;
• Zenith AAA Iliac Plug; and
• Coda® Balloon Catheter.
1 DEVICE DESCRIPTION
1.1 Aortic Main Body and Iliac Leg Components
The Zenith Alpha Abdominal Endovascular Graft is a modular system
consisting of three components: a bifurcated aortic main body and two
iliac legs . (
Fig . 1
) The graft modules are constructed of woven polyester
fabric sewn to self-expanding nitinol stents with braided polyester and
monofilament polypropylene suture . The modules are fully stented to
provide stability and the expansile force necessary to open the lumen of
the graft during deployment . Additionally, the stents provide the necessary
attachment and seal of the graft to the vessel wall .
The bare suprarenal stent at the proximal end of the graft contains barbs
for additional fixation of the device . To facilitate fluoroscopic visualization
of the stent graft, gold radiopaque markers are positioned on both the
main body and iliac leg components . On the main body, four gold markers
are positioned in a circumferential orientation within 2 mm of the most
superior aspect of the graft material, a checkmark (√) is positioned on the
lateral aspect of the most distal stent of the contralateral limb, and two gold
markers are positioned on the most distal stent of the ipsilateral limb . A
marker also is positioned at the bifurcation of the graft .
On each iliac leg graft there are two gold markers on the proximal end, one
showing minimum overlap with the main body on the contralateral side
(16 mm) and one showing maximum overlap with the main body on the
contralateral side (32 mm) . The 16 and 32 mm gold markers are used
for visualization and alignment on the ipsilateral side . A gold marker is
positioned at the most distal end of the iliac leg component . Additionally, if
the graft diameter increases distally, a gold marker is positioned where the
graft begins to increase in diameter .
1.2 Main Body Delivery System
The Zenith Alpha Abdominal Endovascular Graft main body is shipped
preloaded onto an introduction system . (
Fig . 2
) It has a sequential
deployment method with built-in features to provide continuous control
of the endovascular graft throughout the deployment procedure . The
introduction system is designed for precise positioning and allows
readjustment of the final graft position before deployment of the barbed
suprarenal stent .
The main body graft is loaded on a 16 French (6 .0 mm OD) or a 17 French
(6 .5 mm OD) introduction system . Dual locking mechanisms hold the
endovascular graft onto the delivery system until released by the physician .
All systems are compatible with a .035 inch wire guide .
The main body graft delivery system features a Flexor introducer sheath
with a Captor Hemostatic Valve . For added hemostasis, the Captor
Hemostatic Valve can be loosened or tightened for the introduction and/
or removal of ancillary devices into and out of the sheath . The Flexor
introducer sheath resists kinking and is hydrophilically coated . Both features
are intended to enhance trackability in the iliac arteries and abdominal
aorta .
1.3 Iliac Leg Delivery System
The Zenith Alpha Spiral-Z Endovascular Legs are shipped preloaded onto an
introduction system . (
Fig . 3
) The introduction system is designed for ease
of use with minimal preparation and uses a 12 French (4 .7 mm OD) or 14
French (5 .3 mm OD) introducer . All systems are compatible with a .035 inch
wire guide .
For added hemostasis, the Captor Hemostatic Valve can be loosened or
tightened for the introduction and/or removal of ancillary devices into
and out of the sheath . In addition, the delivery system features a Flexor
introducer sheath which resists kinking and is hydrophilically coated .
Both features are intended to enhance trackability in the iliac arteries and
abdominal aorta .
1.4 Zenith Low Profile AAA Endovascular Graft Ancillary Components
Zenith Low Profile ancillary components are compatible with the Zenith
Low Profile AAA Endovascular Graft, as well as the Zenith Alpha Abdominal
Endovascular Graft .
Additional ancillary endovascular components (main body extensions,
converters and iliac plugs) are available . (
Fig . 4
) Ancillary components are
constructed from woven polyester fabric, self-expanding nitinol stents (main
body extensions and converters), self-expanding stainless steel Cook-Z®
stents (iliac plugs), and braided polyester and polypropylene suture .
The aortic main body extensions can be used to provide additional length
to the proximal portion of the endovascular graft . The converters and iliac
plugs can be used to convert a bifurcated graft into an AUI graft, if necessary
(e .g ., cases of Type III endoleak, limb occlusion or unattainable contralateral
limb cannulation) . Additional iliac leg components can also be used as
ancillary components to provide additional length to the distal iliac portion
of the graft system .
1.4.1 Main Body Extensions
Main body extensions utilize 16 French (6 .0 mm OD) or 17 French (6 .5 mm
OD) introduction systems . (
Fig . 40
) The main body extension introduction
system contains a single trigger-wire release mechanism . Deployment of
the main body extension is achieved by sheath retraction and removing the
distal trigger-wire .
To facilitate fluoroscopic visualization of the stent grafts, the main
body extensions have four gold radiopaque markers positioned in a
circumferential orientation within 2 mm of the most superior aspect of the
graft material .
For added hemostasis, the Captor Hemostatic Valve can be loosened or
tightened for the introduction and/or removal of ancillary devices into
and out of the sheath . The main body extension delivery system features a
Flexor introducer sheath which resists kinking and is hydrophilically coated .
Both features are intended to enhance trackability in the iliac arteries and
abdominal aorta .
1.4.2 Converters
Converters utilize 16 French (6 .0 mm OD) or 17 French (6 .5 mm OD)
introduction systems . (
Fig . 30
) The converter introduction system contains
a single trigger-wire release mechanism . Deployment of the converter is
achieved by sheath retraction and removing the distal trigger-wire .
The converter has a single gold radiopaque marker positioned within 2 mm
of the most superior aspect of the graft material . For added hemostasis, the
Captor Hemostatic Valve can be loosened or tightened for the introduction
and/or removal of ancillary devices into and out of the sheath . The converter
delivery system features a Flexor introducer sheath, which resists kinking
and is hydrophilically coated . Both features are intended to enhance
trackability in the iliac arteries and abdominal aorta .
1.4.3 Iliac Plugs
The iliac plug is used to occlude an iliac artery, typically in conjunction with
a femoral-to-femoral crossover procedure . For more information on this
component, please refer to the Zenith AAA Endovascular Graft Ancillary
Components Suggested Instructions for Use .
2 INDICATIONS FOR USE
The Zenith Alpha Abdominal Endovascular Graft and Zenith Low Profile
ancillary components are indicated for the endovascular treatment of
patients with abdominal aortic or aorto-iliac aneurysms having morphology
suitable for endovascular repair, including:
• lIiofemoral access vessel size and morphology (minimal thrombus,
calcification and/or tortuosity) should be compatible with a 16 French
(6.0 mm OD) or 17 French (6.5 mm OD) vascular introducer sheath;
• Non-aneurysmal infrarenal aortic segment (neck) proximal to the
aneurysm:
• with a length of at least 15 mm,
•
with a diameter measured outer wall to outer wall of no greater than
32 mm and no less than 18 mm,
• with an angle less than 60 degrees relative to the long axis of the
aneurysm, and
• with an angle less than 45 degrees relative to the axis of the suprarenal
aorta .
• Iliac artery distal fixation site greater than 10 mm in length and 8 to
20 mm in diameter (measured outer wall to outer wall) .
3 CONTRAINDICATIONS
The Zenith Alpha Abdominal Endovascular Graft is contraindicated in:
• Patients with known sensitivities or allergies to stainless steel, nitinol,
polyester, polypropylene, urethane, PTFE, nylon or gold .
• Patients with a systemic infection who may be at increased risk of
endovascular graft infection .
4 WARNINGS AND PRECAUTIONS
4.1 General
• Read all instructions carefully. Failure to properly follow the instructions,
warnings and precautions may lead to serious consequences or injury to
the patient .
• Always have a qualified surgery team available during implantation or
reintervention procedures in the event that conversion to open surgical
repair is necessary .
• The Zenith Alpha Abdominal Endovascular Graft and introduction
system should only be used by physicians and teams trained in vascular
interventional techniques (catheter-based and surgical) and in the use of
this device . Specific training expectations are described in
Section 9 .1,
Physician Training .
• Additional endovascular interventions or conversion to standard open
surgical repair following initial endovascular repair should be considered
for patients experiencing enlarging aneurysms, unacceptable decrease
in fixation length (vessel and component overlap) and/or endoleak . An
increase in aneurysm size and/or persistent endoleak or migration may
lead to aneurysm rupture .
• Patients experiencing reduced blood flow through the graft limb and/
or leaks may be required to undergo secondary interventions or surgical
procedures .
• When a 42 or 59 mm leg graft is used on the ipsilateral side, contralateral
leg overlap into the contralateral main body limb should be limited to
16 mm . Failure to do so may result in occlusion of the ipsilateral limb .
4.2 Patient Selection, Treatment and Follow-Up
• The Zenith Alpha Abdominal Endovascular Graft is designed to treat
aortic neck diameters no smaller than 18 mm and no larger than
32 mm . The Zenith Alpha Abdominal Endovascular Graft is designed to
treat proximal aortic necks (distal to the lowest renal artery) of at least
15 mm in length . Iliac artery distal fixation site greater than 10 mm in
